FMEA (FAILURE MODE AND EFFECTS ANALYSIS) CHECKLIST

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--- PROCESS DEFINITION & SCOPE ---
[ ] Process Name
[ ] Brief Process Description
[ ] Process Boundaries (Start & End Points)
[ ] Process ID / Part Number (if applicable)
[ ] List of Key Inputs to the Process
[ ] List of Key Outputs from the Process
[ ] Stage of Process (e.g., Design, Setup, Operation, Inspection) (Design, Setup, Operation, Inspection, Maintenance)
[ ] Departments/Teams Involved (Engineering, Manufacturing, Quality, Maintenance, Supply Chain)

--- PROCESS FLOW DIAGRAM & STEP IDENTIFICATION ---
[ ] Process Flow Diagram (PDF, PNG, JPEG)
[ ] Brief Description of the Process
[ ] Total Number of Process Steps Identified
[ ] Step 1: Process Step Description
[ ] Step 1: Process Step Number
[ ] Step 2: Process Step Description
[ ] Step 2: Process Step Number
[ ] Notes on Step Definition and Boundaries
[ ] Process Flow Diagram Accuracy Assessment (Initial Review) (Accurate and Complete, Requires Minor Adjustments, Requires Significant Revision)

--- POTENTIAL FAILURE MODES ---
[ ] Failure Mode 1: Describe the specific way the process step could fail.
[ ] Failure Mode 2: Describe the specific way the process step could fail.
[ ] Failure Mode 3: Describe the specific way the process step could fail.
[ ] Failure Mode 4: Describe the specific way the process step could fail.
[ ] Failure Mode 5: Describe the specific way the process step could fail.
[ ] Failure Mode 10: Describe the specific way the process step could fail.

--- POTENTIAL EFFECTS OF FAILURE ---
[ ] Immediate Impact on Product Quality
[ ] Impact on Subsequent Processes
[ ] Impact on Customer Satisfaction
[ ] Impact on Safety (Operator or Environment)
[ ] Impact on Regulatory Compliance
[ ] Potential for Product Recall or Warranty Claims
[ ] Impact on Production Schedule or Throughput

--- POTENTIAL CAUSES OF FAILURE ---
[ ] Material Supplier Quality Issues
[ ] Equipment Maintenance Deficiencies (Lack of Preventative Maintenance, Incorrect Lubrication, Calibration Errors, Worn Components)
[ ] Process Parameter Drift (e.g., Temperature)
[ ] Operator Training Gaps
[ ] Design Error (if applicable) (No Error, Material Specification Error, Dimensional Error, Process Instruction Error)
[ ] Environmental Factors (e.g., Humidity, Vibration)
[ ] Cycle Time Variation
[ ] Tooling Wear/Damage (No Wear/Damage, Minor Wear, Significant Wear, Damage)

--- SEVERITY RATING (S) ---
[ ] Define Severity Scale
[ ] Severity Rating (S) - Product Impact (1 - No Effect, 2 - Minor Defect (Cosmetic), 3 - Moderate Defect (Functional, Repairable), 4 - Major Defect (Non-Functional, Significant Repair Required), 5 - Catastrophic Failure (Unsafe, Total Loss))
[ ] Justification for Selected Severity Rating
[ ] Severity Rating (S) - Customer Impact (1 - No Impact, 2 - Minor Inconvenience, 3 - Moderate Dissatisfaction, 4 - Significant Dissatisfaction/Complaint, 5 - Safety Risk/Legal Action)
[ ] Numerical Severity Value (for Calculation)
[ ] Documentation of Assessment

--- OCCURRENCE RATING (O) ---
[ ] Define Occurrence Rating Scale (1: Remote, 2: Occasional, 3: Low, 4: Moderate, 5: High, 6: Very High)
[ ] Occurrence Rating
[ ] Justification for Occurrence Rating
[ ] Contributing Factors to Occurrence (Operator Error, Equipment Malfunction, Material Variation, Process Parameter Drift, Environmental Conditions, Maintenance Issues, Design Flaw)
[ ] Data/Source Used for Rating
[ ] Historical Occurrence Data (if available)
[ ] Rating Confidence Level (High, Moderate, Low)

--- DETECTION RATING (D) ---
[ ] Existing Control/Inspection Method? (Yes, Formal Inspection, Yes, Informal Observation, Yes, Automated System, No, None Currently Exists)
[ ] Detection Rating (D) - Scale 1-10 (10=Perfect Detection)
[ ] Justification for Detection Rating (D)
[ ] Type of Control/Inspection (Visual Inspection, Measurement, Testing, Statistical Process Control (SPC), Other)
[ ] Describe the Current Detection Method in Detail
[ ] Effectiveness of Current Detection Method? (Highly Effective, Moderately Effective, Minimally Effective, Not Effective)
[ ] Potential Improvements to Current Detection Method

--- RISK PRIORITY NUMBER (RPN) CALCULATION ---
[ ] Severity Rating (S)
[ ] Occurrence Rating (O)
[ ] Detection Rating (D)
[ ] RPN (S x O x D)
[ ] RPN Justification/Notes
[ ] Is RPN > Threshold? (Yes, No)
[ ] Threshold Value (If Applicable)

--- RECOMMENDED ACTIONS ---
[ ] Detailed Description of Recommended Action
[ ] Estimated Cost of Action (USD)
[ ] Action Priority (High, Medium, Low) (High, Medium, Low)
[ ] Target Implementation Date
[ ] Responsible Department (Engineering, Manufacturing, Quality, Maintenance, Procurement)
[ ] Responsible Person/Team
[ ] Supporting Documentation (e.g., Drawings, Specifications)
[ ] Action Type (Select all that apply) (Process Change, Equipment Modification, Training, Design Change, Supplier Change)
[ ] Justification for Selected Action

--- ACTION IMPLEMENTATION & VERIFICATION ---
[ ] Planned Completion Date for Action
[ ] Estimated Cost of Action Implementation (USD)
[ ] Detailed Description of Action Implementation
[ ] Person Responsible for Action Implementation (John Doe, Jane Smith, David Lee)
[ ] Supporting Documentation (e.g., SOP changes, training records)
[ ] Date of Verification/Validation
[ ] Description of Verification Method (how was the action verified)
[ ] Verification Result (Pass/Fail) (Pass, Fail)
[ ] Comments/Notes on Verification Results

--- RE-EVALUATION & RPN UPDATE ---
[ ] Date of Re-evaluation
[ ] Summary of Changes Made (Brief Description)
[ ] New Severity Rating (S) for each failure mode
[ ] New Occurrence Rating (O) for each failure mode
[ ] New Detection Rating (D) for each failure mode
[ ] New RPN Calculated (S x O x D)
[ ] Did the action effectively reduce the risk? (Yes, No, Partially)
[ ] Explanation/Justification for any rating changes.
[ ] Supporting Documentation (e.g., test results, inspection reports)
[ ] Next Review Date

--- DOCUMENTATION & REVIEW ---
[ ] FMEA Document Revision History
[ ] Date of Last FMEA Review
[ ] FMEA Document Version Number
[ ] Review Status (Not Reviewed, Review Complete, Revision Required)
[ ] Summary of Review Findings/Comments
[ ] Supporting Documentation (e.g., revised process maps)
[ ] Reviewer Signature
[ ] Reviewer Name (Printed)

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